National Library of Medicine; Notice of Closed Meeting, 38461 [E8-15080]
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Federal Register / Vol. 73, No. 130 / Monday, July 7, 2008 / Notices
mstockstill on PROD1PC66 with NOTICES
entitled, ‘‘Draft Guidance for Industry:
Use of Nucleic Acid Tests to Reduce the
Risk of Transmission of West Nile Virus
From Donors of Whole Blood and Blood
Components Intended for Transfusion
and Donors of Cells, Tissues, and
Cellular and Tissue-Based Products
(HCT/Ps),’’ that published April 28,
2008. The agency is taking this action to
allow interested persons to submit
complete data from the 2008 West Nile
Virus season concerning the criteria for
converting from minipool nucleic acid
tests (NAT) to individual donation NAT
for donations of Whole Blood and blood
components for transfusion.
DATES: Submit requested data by
January 31, 2009.
ADDRESSES: Submit written data,
identified by Docket No. FDA–2008–D–
0233, to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit data
in electronic format to https://
www.regulations.gov. For additional
information on submitting data, see the
‘‘Request for Data’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document. Under 21 CFR
10.115(g)(5), comments on guidance
documents can be submitted at any
time; comments may be submitted to the
addresses specified previously.
FOR FURTHER INFORMATION CONTACT:
Tami Belouin, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of April 28,
2008 (73 FR 22958), FDA published a
notice announcing the availability of the
draft guidance entitled, ‘‘Draft Guidance
for Industry: Use of Nucleic Acid Tests
to Reduce the Risk of Transmission of
West Nile Virus From Donors of Whole
Blood and Blood Components Intended
for Transfusion and Donors of Human
Cells, Tissues, and Cellular and TissueBased Products (HCT/Ps).’’ The draft
guidance provides recommendations for
testing of donations of Whole Blood and
blood components and HCT/P donor
specimens for West Nile Virus (WNV)
using an FDA-licensed donor screening
assay. FDA requested that comments on
this draft guidance be submitted within
90 days of publication. The 90-day
comment period ends on July 28, 2008.
Based on FDA’s consideration of
input received to date, we believe that
data collected during the 2008 WNV
season will be important information
that we should obtain prior to finalizing
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recommendations on criteria for
converting from minipool NAT to
individual donation NAT for donations
of Whole Blood and blood components
for transfusion. However, the 2008 WNV
season will extend beyond the 90-day
comment period for this draft guidance.
We are concerned that extending the
comment period until the end of the
WNV season would significantly delay
finalization of the draft guidance, which
contains additional recommendations
regarding testing of donations of Whole
Blood and blood components for
transfusion and HCT/P donor
specimens. Based on these
considerations, FDA is retaining the 90day comment period for the draft
guidance (ending July 28, 2008).
However, we do not intend to finalize
the proposed recommendations on
conversion from minipool NAT to
individual donation NAT until
obtaining additional data from the 2008
WNV season. We are requesting the
submission, on or before January 31,
2009, of complete data collected during
the 2008 WNV season relating to the
criteria for converting from minipool
NAT to individual NAT. FDA intends to
finalize the draft guidance as soon as it
is practicable, but may finalize the
criteria for conversion to individual
donation NAT in a subsequent guidance
document after reviewing the additional
2008 data.
II. Request for Data
FDA requests the submission, on or
before January 31, 2009, of complete
data collected during the 2008 WNV
season relating to the criteria for
converting from minipool NAT to
individual donation NAT. Interested
persons may submit to the Division of
Dockets Management (see ADDRESSES)
written or electronic data. Submit a
single copy of electronic data or two
paper copies of any mailed data, except
that individuals may submit one paper
copy. Data are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments are available for public
examination in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic data or
submissions will be accepted by FDA
only through FDMS at https://
www.regulations.gov.
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III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/cber/guidelines.htm
or https://www.regulations.gov.
Dated: June 30, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–15368 Filed 7–3–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Library of Medicine; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Biomedical Library
and Informatics Review Committee.
Date: November 6–7, 2008.
Time: November 6, 2008, 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Library of Medicine,
Building 38, Board Room, 2nd Floor, 8600
Rockville Pike, Bethesda, MD 20892.
Time: November 7, 2008, 8 a.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Library of Medicine,
Building 38, Board Room, 2nd Floor, 8600
Rockville Pike, Bethesda, MD 20892.
Contact Person: Arthur A Petrosian, PhD,
Scientific Review Administrator, Division of
Extramural Programs, National Library of
Medicine, 6705 Rockledge Drive, Suite 301
Bethesda, MD 20892–7968, 301–496–4253,
petrosia@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.879, Medical Library
Assistance, National Institutes of Health,
HHS)
Dated: June 26, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–15080 Filed 7–3–08; 8:45 am]
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[Federal Register Volume 73, Number 130 (Monday, July 7, 2008)]
[Notices]
[Page 38461]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-15080]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Library of Medicine; Notice of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice is hereby given of the following
meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: Biomedical Library and Informatics Review
Committee.
Date: November 6-7, 2008.
Time: November 6, 2008, 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant applications.
Place: National Library of Medicine, Building 38, Board Room,
2nd Floor, 8600 Rockville Pike, Bethesda, MD 20892.
Time: November 7, 2008, 8 a.m. to 2 p.m.
Agenda: To review and evaluate grant applications.
Place: National Library of Medicine, Building 38, Board Room,
2nd Floor, 8600 Rockville Pike, Bethesda, MD 20892.
Contact Person: Arthur A Petrosian, PhD, Scientific Review
Administrator, Division of Extramural Programs, National Library of
Medicine, 6705 Rockledge Drive, Suite 301 Bethesda, MD 20892-7968,
301-496-4253, petrosia@mail.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.879,
Medical Library Assistance, National Institutes of Health, HHS)
Dated: June 26, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E8-15080 Filed 7-3-08; 8:45 am]
BILLING CODE 4140-01-M
